Multi-center Validation Study of a Large Language Model-based Intelligent Agent for Blood Cell Analysis

Fudan University

Status: Not yet enrolling

Conditions: Complete Blood Count Review

Treatments: Other: LLM-Assisted Review Group

Study type: Observational

Funder types: Other

Identifiers

NCT07607184

KY2026-084

Details and patient eligibility

About

I. Study Background: Currently, in most medical institutions, the review of blood cell analysis still heavily relies on manual verification by laboratory staff. This process requires a comprehensive analysis of instrument parameters, alarm flags, historical comparison results, and, when necessary, microscopic examination. However, with the increasing volume of test samples and the high concentration of review tasks during peak hours, the traditional manual review model increasingly shows problems such as prolonged turnaround time (TAT), uneven workload distribution, and decreased consistency in reviews. In recent years, intelligent review systems based on Large Language Models (LLM) have shown potential in analyzing abnormal results and stratifying sample risks by integrating preset rules, clinical diagnostic information, and multi-dimensional laboratory data, which is expected to optimize the review workflow.

II. Study Objective: To evaluate the difference in overall sample review turnaround time between the experimental process and the control process during the formal study phase, and to test its superiority.

III. Subjects: The investigators need to recruit approximately 20,000 subjects, regardless of age or gender.

IV. Study Procedures: If participants agree to participate in the study, participants only need to allow us to use participants test results after participants have completed your routine blood test (CBC).

V. Risks and Benefits:

1. Risks: This study poses no risk to the subjects. The investigators only use the result data of patients after participants have had their routine blood test; there is no need for patients to undergo additional blood draws.
2. Benefits: It will shorten the turnaround time for routine blood test results and share the workload of doctors in reviewing these results.

VI. Privacy: All of participants information will be kept strictly confidential and will only be used for this scientific research.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who underwent routine blood tests in the outpatient, emergency, or inpatient departments of the participating centers during the study period.

Corresponding samples must have complete instrument results, review trails, and report timestamp records.

Approved for inclusion by the Ethics Committee.

Exclusion criteria

• Samples collected during periods of instrument malfunction or interface transmission anomalies.

Missing key research data, particularly samples where the final review conclusion or key timestamps cannot be confirmed.

Subjects or their legal representatives explicitly refuse to participate in the study.

Trial design

20,000 participants in 2 patient groups

LLM-Assisted Review Group

Treatment:

Other: LLM-Assisted Review Group

Standard Manual Review Group